K243041
- 510(k) number
- K243041
- Device name
- contact forte Alpha
- Applicant
- Bhm-Tech Produktionsgesellschaft Mbh AT
- Product code
- LXB — Hearing Aid, Bone Conduction
- Decision date
- 2025-04-25
- Date received
- 2024-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K243041.pdf
Official FDA record: K243041
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.